Am Heegwald 11 · 76227 Karlsruhe · Germany

Aseptic powder dosing from Romaco – integral line solutions

As globally renowned specialist for aseptic lines, Romaco supports its customers when planning and installing a new aseptic line: beginning from the feasibility study through to validation. In this way, the company creates a trustful basis for long-term cooperation. The line solutions can be individually adjusted to the process and production requirements of the customers and combined with other systems without any problems.

The following applies for all single machines and lines from Romaco:

High quality standards

  • Suitable for the operation in conventional clean rooms and with isolator
  • Barrier technology (RABS) optionally available
  • Equipped with in-line product quality control
  • Statistical process monitoring possible
  • Monitoring of viable and non-viable particles
  • Special project management with a contact person

Real-time quality control

  • Process analytical technology system in accordance with FDA and EMEA
  • Improved operational safety thanks to automation
  • Management of process variables
  • Reduction of the global cycle time of the production thanks to online measurements and monitoring
  • Less rejection and rework thanks to the greatest possible automation

Validation in accordance with GAMP standards

  • Acceptance test at the manufacturers' site (FAT) and the customers' site (SAT)
  • Design qualification (DQ)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Performance qualification (PQ)